U.S. agencies clash over who should regulate genetically engineered livestock

A disease that kills millions of pigs a year may soon meet its match — if two federal agencies can agree on the idea.

Porcine reproductive and respiratory syndrome virus is one of the latest examples of a condition that scientists believe they can beat with genetic engineering, and one that's caught up in a disagreement between the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) over how quickly such methods should be approved, and by whom.

On one side: FDA Commissioner Scott Gottlieb, whose agency regulates genetically engineered food similarly to a drug. On the other: Agriculture Secretary Sonny Perdue, pushing for faster approvals of a wide range of biotechnology that could block animal diseases and help cows produce more milk, among other benefits.

"I think Dr. Gottlieb and I have disagreed about FDA's position on that," Perdue said yesterday at a U.S. House of Representatives agriculture appropriations subcommittee hearing.

Perdue said he worries that FDA's regulations on biotech animals could stifle innovation and slow the introduction of animals that could be more productive or resistant to diseases without the use of drugs or hormones. USDA already allows genetic engineering in plants, and Perdue said he sees livestock in a similar way.

In its draft guidance, FDA said prior authorization is necessary before introducing any food from such livestock into the food supply. The agency would review any possible health risks, according to the guidance. Authorization would also be needed before shipping any such animals, FDA said.

The work on the pig virus is the first step of a partnership between Caribou Biosciences Inc. and Genus PLC, which last year announced a four-year research project that could be extended for an additional three years. Caribou is based in Berkeley, California, and Genus is based in the United Kingdom.

Scientists can inactivate a single gene in the pig to stop production of a protein the virus needs to survive, according to the companies. That practice—called gene editing—doesn't involve inserting genes from another species and isn't the same as genetic modification.

The virus didn't come up at the hearing, but pigs did, thanks to Rep. David Young (R-IA), whose state leads the country in hog production.

Young took issue with FDA's position that biotech animals should be regulated similarly to drugs, which he called an "onerous" approach.

"I love bacon, but I don't know that I'm addicted to it, or it's a drug," Young said. "It sounds bizarre to me."

Advocates for biotechnology say the regulatory regime may put too much restriction on methods that fall short of genetically modified organisms, or GMOs.

"Perhaps that system doesn't work so well," said Karen Batra, a spokeswoman for the Biotechnology Innovation Organization. "There's a lot of confusion in the process. It takes an amazing amount of time."

The system might work better, Batra said, if gene editing weren't regulated like a drug, as GMOs are.

The fight over biotech livestock plays out in Congress, as well, where Sen. Lisa Murkowski (R-AK) has led a fight against genetically modified salmon, fearing they could undermine the fishing industry in her state (Greenwire, May 19, 2016).

I love bacon, but I don't know that I'm addicted to it, or it's a drug. It sounds bizarre to me.

Representative David Young (R–IA)

Some lawmakers, including Rep. Ted Yoho (R-FL), have called for switching jurisdiction from FDA to USDA. But USDA doesn't have regulations written to handle biotech livestock, said Jaydee Hanson, a senior policy analyst at the Center for Food Safety in Washington, D.C., an organization critical of genetic engineering.

"They're saying, 'We don't have any regulation, so we're not going to regulate it,'" Hanson said.

Among other measures, the government should require a complete sequencing of the genome for any genetically tweaked animal that might enter the food supply, Hanson said.

The issue is likely to be debated in the 2018 farm bill. At a markup yesterday of the House Agriculture Committee's farm bill, Yoho offered, then withdrew, an amendment requiring a report on moving jurisdiction to USDA.